Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Participants were treated at the Substance Treatment and Research Service (STARS) of Columbia University/ New York State Psychiatric Institute (NYSPI). Study enrollment occurred from January 2010 through May 2014 with study completion in September 2014.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

The study included a one-week placebo lead-in phase. Participants were randomized at the end of the placebo lead-in phase and those who reported marijuana use less than once a week during the lead-in phase were considered placebo responders and were not randomized. A total of 34 participants discontinued prior to randomization for various reasons.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Placebo

Lofex. matched placebo Dronabinol placebo

Placebo: Placebo control

Lofexidine and Dronabinol

Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol

Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID

Total

Total of all reporting groups

Baseline Measures

Placebo

Lofexidine and Dronabinol

Total

Overall Participants Analyzed [Units: Participants]

61

61

122

Age [Units: Years]Mean (Standard Deviation)

35.4 (10.8)

34.8 (11.2)

35.2 (10.9)

Gender [Units: Participants]

Female

16

22

38

Male

45

39

84

Race/Ethnicity, Customized [Units: Participants]

Hispanic

15

17

32

Black

17

18

35

White

26

21

47

Other

3

5

8

Outcome Measures

1. Primary:

21 Days of Consecutive Abstinence as Measured by the Time-line Followback. [ Time Frame: reported daily for 12 weeks/ or study participation ]